Clinical Notes: Metal Hip Liner Pulled

The metal-on-metal hip implant debacle appears to have claimed another casualty -- a metal hip socket liner marketed by the British firm Smith & Nephew, which said it was pulling the product from the market.

"We regularly review the effectiveness of our products and are not satisfied with the clinical results of this component," an optional metal liner in the R3 Acetabular System, a company press release said.

Annual revision rates in patients with the device were 1.6%, a Smith & Nephew official told Reuters, well above the 1% rate deemed acceptable by Britain's drug and device evaluation center.

The company said 7,700 of the liners had been implanted since it was introduced in 2009.

In 2010, the DePuy unit of Johnson & Johnson recalled a metal-on-metal system for similar reasons. Marketing of others has been quietly terminated and the popularity of metal-on-metal systems has plummeted to less than 5% of the hip replacement market, by some estimates.

Metal-on-metal hip implants generally have been linked to high rates of revision surgery and systemic complications, apparently because of component erosion and leaching of metal ions both locally and into circulation. The FDA is currently considering whether to regulate the devices more strictly.

Consumer Reports to Rate Mass. Docs

The popular what-to-buy magazine Consumer Reports will shortly include a 25-page insert for Massachusetts subscribers, showing results of patient surveys on their experiences with 487 primary care physician practices in the state.

Ratings will be presented in similar fashion to the magazine's evaluations of toasters and washing machines, with 1-to-5 scales for such measures as "how well doctors communicate" and "timely appointments, care, and information."

Consumer Reports has previously published evaluations of physicians but only on its website. The magazine has also produced ratings of hospitals, cardiac surgery groups, and prescription drugs.

The Massachusetts physician ratings represent the first rollout of what is planned to be a multistate effort. Minnesota and Wisconsin are next up.

A Picture of Chemobrain

Cancer patients have long complained of "chemobrain," a loss of mental acuity during and after chemotherapy. Now researchers led by Halle Moore, MD, of the Cleveland Clinic, have shown that the subjective experience of chemobrain is paralleled by electroencephalographic changes.

Eight women planning to undergo adjuvant chemotherapy for operable breast cancer were matched with age-similar controls and tested for neurophysiologic changes. The researchers, reporting at the annual meeting of the American Society of Clinical Oncology in Chicago, found that patients' mental fatigue increased significantly during chemo, while controls registered no change, and then recovered so that there was no difference after a year. There was no difference in cognitive processing speed.

EEG activity before chemo and a year afterward did not differ between patients and controls, they found, but during chemo EEG total spectrum amplitudes in patients were significantly greater than in controls at rest and following both the cognitive and physical tasks (at P=0.05, P<0.001, and P<0.001, respectively).

And for patients during chemo -- but not for the controls -- EEG readings taken after the cognitive task had greater amplitude than those taken before, a difference that was significant at P=0.012. The trend was similar for the physical task but fell short of significance.

Novel RA Drug Falls by Wayside

An investigational drug for rheumatoid arthritis failed to outperform the current drug it was modeled after in a phase II trial, resulting in a halt to its clinical development.

Called CH-4051 and developed by Chelsea Therapeutics, the agent is a non-metabolized antifolate drug derived from methotrexate, the standard first-line disease-modifying drug for rheumatoid arthritis. The company had expected from preclinical research that the analog would be more effective than methotrexate.

But in a 244-patient dose-ranging trial, the new drug was actually less effective than methotrexate, prompting Chelsea to pull the plug on the program.

In a press release, a company official blamed an "unexpectedly robust response" in patients treated with methotrexate. A 20% reduction in symptoms was achieved by 56% of patients taking methotrexate for 12 weeks, compared with 37% to 46% of those receiving CH-4051 at various doses.

Chelsea had hoped the drug could be used for a variety of inflammatory conditions and cancers in addition to rheumatoid arthritis.

Michael Smith, North American correspondent, contributed to this report.

POPULAR IN YOUR SPECIALTY

MedPageToday is a trusted and reliable source for clinical and policy coverage that directly affects the lives and practices of health care professionals.

Physicians and other healthcare professionals may also receive Continuing Medical Education (CME) and Continuing Education (CE) credits at no cost for participating in MedPage Today-hosted educational activities.